Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-02-15

Brief Summary

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This study will investigate whether applying high mechanical index (MI) impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent (UEA) microbubble infusion will result in subclinical improvement in left ventricle systolic function.

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Detailed Description

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The purpose of this study is to investigate whether applying high MI impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent(UEA) microbubble infusion will result in subclinical improvement in LV systolic function detected by left ventricular outflow tract velocity time integral (LVOT VTI).

Conditions

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Cardiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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high MI

patients receiving high MI impulses

Group Type EXPERIMENTAL

high MI impulses

Intervention Type DIAGNOSTIC_TEST

patients will receive intermittent high MI impulses(\>1.0) in addition to low MI imaging. LVOT VTI will be measured at different times per protocol.

low MI

patients receiving low MI impulses

Group Type ACTIVE_COMPARATOR

low MI impulses

Intervention Type DIAGNOSTIC_TEST

patients will receive low MI imaging only. LVOT VTI will be measured at different times per protocol.

Interventions

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high MI impulses

patients will receive intermittent high MI impulses(\>1.0) in addition to low MI imaging. LVOT VTI will be measured at different times per protocol.

Intervention Type DIAGNOSTIC_TEST

low MI impulses

patients will receive low MI imaging only. LVOT VTI will be measured at different times per protocol.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

age 19 years or older

Exclusion Criteria

1. severe aortic valve stenosis
2. pregnant or lactating women
3. atrial fibrillation
4. very poor image quality despite contrast use.
5. unstable cardiac condition such as cardiogenic shock.
6. allergy to UEA
7. presence of right to left or bidirectional shunts.
8. Patients on mechanical circulatory support.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes